OBJECTIVE: To determine the clinical effectiveness of self management compared with routine care in patients on long term oral anticoagulants. DESIGN: Multicentre open randomised controlled trial. SETTING: Midlands region of the UK. PARTICIPANTS: 617 patients aged over 18 and receiving warfarin randomised to intervention (n = 337) and routine care (n = from 2470 invited; 193/337 (57%) completed the 12 month intervention. INTERVENTION: Intervention patients used a point of care device to measure international normalised ratio twice a week and a simple dosing chart to interpret their dose of warfarin. MAIN OUTCOME MEASURE: Percentage of time spent within the therapeutic range of international normalised ratio. RESULTS: No significant differences were found in percentage of time in the therapeutic range between self management and routine care (70% v 68%). Self managed patients with poor control before the study showed an improvement in control that was not seen in the routine care group. Nine patients (2.8/100 patient years) had serious adverse events in the self managed group, compared with seven (2.7/100 patient years) in the routine care arm (chi2(df = 1) = 0.02, P = 0.89). CONCLUSION: With appropriate training, self management is safe and reliable for a sizeable proportion of patients receiving oral anticoagulation treatment. It may improve the time spent the therapeutic range for patients with initially poor control. Trial registration ISRCTN 19313375.
RCT Entities:
OBJECTIVE: To determine the clinical effectiveness of self management compared with routine care in patients on long term oral anticoagulants. DESIGN: Multicentre open randomised controlled trial. SETTING: Midlands region of the UK. PARTICIPANTS: 617 patients aged over 18 and receiving warfarin randomised to intervention (n = 337) and routine care (n = from 2470 invited; 193/337 (57%) completed the 12 month intervention. INTERVENTION: Intervention patients used a point of care device to measure international normalised ratio twice a week and a simple dosing chart to interpret their dose of warfarin. MAIN OUTCOME MEASURE: Percentage of time spent within the therapeutic range of international normalised ratio. RESULTS: No significant differences were found in percentage of time in the therapeutic range between self management and routine care (70% v 68%). Self managed patients with poor control before the study showed an improvement in control that was not seen in the routine care group. Nine patients (2.8/100 patient years) had serious adverse events in the self managed group, compared with seven (2.7/100 patient years) in the routine care arm (chi2(df = 1) = 0.02, P = 0.89). CONCLUSION: With appropriate training, self management is safe and reliable for a sizeable proportion of patients receiving oral anticoagulation treatment. It may improve the time spent the therapeutic range for patients with initially poor control. Trial registration ISRCTN 19313375.
Authors: M E Cromheecke; M Levi; L P Colly; B J de Mol; M H Prins; B A Hutten; R Mak; K C Keyzers; H R Büller Journal: Lancet Date: 2000-07-08 Impact factor: 79.321
Authors: A P A Gadisseur; W G M Breukink-Engbers; F J M van der Meer; A M H van den Besselaar; A Sturk; F R Rosendaal Journal: Arch Intern Med Date: 2003-11-24
Authors: D McCahon; E T Murray; S Jowett; H S Sandhar; R L Holder; S Hussain; B O'Donoghue; D A Fitzmaurice Journal: J Clin Pathol Date: 2007-01-26 Impact factor: 3.411
Authors: Rowena J Dolor; R Lynne Ruybalid; Lauren Uyeda; Robert G Edson; Ciaran Phibbs; Julia E Vertrees; Mei-Chiung Shih; Alan K Jacobson; David B Matchar Journal: J Thromb Thrombolysis Date: 2010-10 Impact factor: 2.300
Authors: Annette Plüddemann; Matthew Thompson; Jane Wolstenholme; Christopher P Price; Carl Heneghan Journal: Br J Gen Pract Date: 2012-11 Impact factor: 5.386
Authors: Daniel M Witt; Robby Nieuwlaat; Nathan P Clark; Jack Ansell; Anne Holbrook; Jane Skov; Nadine Shehab; Juliet Mock; Tarra Myers; Francesco Dentali; Mark A Crowther; Arnav Agarwal; Meha Bhatt; Rasha Khatib; John J Riva; Yuan Zhang; Gordon Guyatt Journal: Blood Adv Date: 2018-11-27